Study On The Preparation And The Quality Standard Of QM Granules

Diabetic retinopathy is an illness that might be caused by diabetic hurt to eyes'vein,which is the main reason that results in the blindness of people ranging from the age of 20 to 65.So it is important to select suitable medication.The purpose of this project is to reseach a safe,effective medicament that can prevent and cure such disease.QM granules is made up of Radix Astragali,Radix Puerariae,Radix Rehmanniae, Fructus Lycii,Cassia Seed,Motherwort Fruit,Cattall Pollen and Hirudo.This drug has potential to treat diabetic retinopathy with the accompanying sympotoms "Qi,Yin" deficiency,deficiency of liver and kidney and hypostasis.The preparation procedure,quality standard and stability of the QM granules were systematically studied in this thesis.1.Studies on the preparation of QM granulesEthanol and water decoction was successively used for the extraction through comparison of different methods.The contents of total nitrogen,flavonoids and puerarin were selected as the evaluating index to determine the optimal conditions of ethanol extraction.The concentration and amount of ethanol,extraction time were selected by L₉(3⁴ ) ortnogonal design and the analysis of variance.The optimal conditions for the ethanol extraction were as follows:65%ethanol,8 times the amount of herb material,decocted 2 hoursThe content of total polysaccharide was chosen as an assessing index to determine the optimum conditions of water extraction.The amount of water, temperature and time,the number of decoction were selected by ortnogonal design and the analysis of variance.Finally,the optimum conditions for the extraction of total polysaccharide were as follows:12 times of water,decocted twice at 100℃, each time lasted 2 hours.The alcohol extract which recovered alcohol was mixed with the water extract in which impurity had been removed by high-speed centrifugation.The mixture was concentrated under reduced pressure to get the equivalent extract with relative density of 1.10-1.12,then the preparation was obtained by spray drier and fluid bed granulating drier.The optimal drying condition of the extract was 180±2℃for inlet air temperature and 85±2℃for exit air temperature.The optimal drying condition of the granule was 70±2℃for inlet air temperature and 50±2℃for exit air temperature. The majority of particle size was between 14 mesh and 40 mesh.The water content of granule was not more than 6%.To improve the process,other three batches of drugs were prepared.The results of routine quality analysis showed that the process was feasible.2.Study on the quality standard and stability of QM granulesIn the quality control study,thin layer chromatography(TLC) was used for identification of Radix Astragali,Radix Rehmanniae,Fructus Lycii and Cassia Seed. The results suggested that TCL was simple,rapid method for qualitative control of the preparation.A RP-HPLC method was developed for the quantitative determination of puerarin in QM granules.It was suggested that the content of puerarin was not less than 0.62%.Finally,the stability of the preparation was invesigated,long-term stability test showed that these drugs packed in laminated films and pouches were stable.